Browsing by Subject "Diagnostic Testing"

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    Home testing for COVID-19: lessons from direct to consumer genetics
    (Springer Nature, 2020-06-16) Wilson, Theodore E.; Halverson, Colin; Medical and Molecular Genetics, School of Medicine
    On March 11th, 2020, COVID-19 was declared a worldwide pandemic. Publicly available testing has lagged, and tech entrepreneurs have quickly volunteered to fill this gap. Over the last two decades, genetic testing ordered outside of a clinic and without the involvement of a physician has been a way for the average individual to get genetic testing. In this commentary, we discuss the lessons learned from this parallel case from genetics and suggest regulatory caution in establishing direct-to-consumer COVID testing.
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    Rigorous and consistent evaluation of diagnostic tests in children: another unmet need
    (Springer Nature, 2020-09-06) Caldwell, Christine S.; Denne, Scott C.; Pediatrics, School of Medicine
    It is time for the pediatric community, along with the FDA and the device industry, to renew efforts to better provide appropriately evaluated devices and diagnostic tests for children. This will require seriously considering incentives and/or funding for pediatric trials, improving insurance coverage to reimburse for device use, and creative approaches to the evaluation process in children. In the meantime, the FDA should work to better communicate the device and diagnostic test regulatory process to the public and physicians, and make clear to pediatricians to what extent specific diagnostic tests and devices have and have not been evaluated in children.